Do you think the US cosmetic industry needs more regulation?

PerryPerry Administrator, Professional Chemist
We're hosting a webinar on EU/UK Cosmetic Regulations in early May.

You can register for free here.

But thinking about the topic and seeing all the buzz about the recent "Not So Pretty" HBO documentary, it got me thinking. 

Does the US cosmetic industry really need more regulating? (Why or why not?)

If so, what should that be?

I'll let you know what I think after a few other people weigh in.

Comments

  • I would love to see a small 'barrier to entry' for individuals seeking to sell cosmetic products to the public.  I think (do not know) that the EU has some kind of minimal testing, and ingredient review for individuals looking to sell to the public.

    As someone that interacts with the beginners... it just absolutely instills 'shock and awe' in me...of what they want to sell.

    How many times have I heard this... "I made my first emulsion this week, it is not stable and beginning to mold, but I really like it, and want to start selling it next week."   No exaggeration...this type of statement is very common.

    The public deserves to be protected from this.
  • PerryPerry Administrator, Professional Chemist
    @Graillotion - ironically, the new legislation looks to include a minimum sales barrier. This means if your sales are below that minimum, the new standards don't apply to you. Pretty much the opposite of your completely reasonable suggestion.

  • I would love to see a small 'barrier to entry' for individuals seeking to sell cosmetic products to the public.  I think (do not know) that the EU has some kind of minimal testing, and ingredient review for individuals looking to sell to the public.

    As someone that interacts with the beginners... it just absolutely instills 'shock and awe' in me...of what they want to sell.

    How many times have I heard this... "I made my first emulsion this week, it is not stable and beginning to mold, but I really like it, and want to start selling it next week."   No exaggeration...this type of statement is very common.

    The public deserves to be protected from this.

    As someone existing in a similar space who sees this kind of thing frighteningly often, I can confirm that feeling and type of statement. I agree that there should be some kind of barrier to entry. Perhaps not allowing people to sell cosmetics products (other than true soap) unless they register as a business and pay a small insurance bond.
    @Perry I think that the problem is probably not a dearth of regulation as much as it is consumer ignorance, the death of expertise, and lobbyists. More laws or regulations might be a good thing, such as requiring ingredients lists on household products. But the flip side is the utter absurdity that is CA Prop 65 cancer warnings.
  • Bill_TogeBill_Toge Member, Professional Chemist
    as far as I can tell (speaking as a complete outsider both to the USA and its cosmetics industry), the regulations are sufficient, but the FDA is incredibly overstretched in carrying out the enforcement of said regulations, meaning that a lot can slip under the radar
    a good first step would be for the enforcement to be devolved to state-level agencies, as is done in Europe, and having the FDA coordinate all the data from those agencies
    UK based cosmetic chemist with 13 years' experience at the bench. I've worked with pretty much everything apart from pressed powders, soap, solid lipstick and aerosols.
  • @Perry or others, I have seen the reference to the HBO documentary several times now.  I am completely unfamiliar with what they said, or the premise.

    Is this something that is horrible misinformation and media spin... or is this something that is well done and accurate?

    Also...I do not have TV of any kind...(sorry, gathering knowledge takes precedent over entertainment)... is there another format I can view this?  Amazon Prime, YouTube....etc???

    I would like to view it...no matter which category it falls into.
  • SylSyl Member
    I agree with lack of enforcement, from what I have noticed some small companies selling in the US do not follow basic INCI labeling, and they also sell their cosmetics at Whole Foods, nobody cares.  It is an invitation not to follow the rules... 
  • PhilGeisPhilGeis Member, Professional formulator
    The industry has been successful to this point in terms of health risks - chemical and microbiological - as good as anywhere in the world. 

    Statutes proposed - before covid - ranged from EWG-like craziness banning preservatives to industry (PCPC)-supported, mildly-odd Feinstein Collins.  The big guys support as its what they're already doing.  It largely lets little guys off the hook
     
    To the extent there are risks, they're the politically-correct priority chemical lists and small manufacturers with natural preservative and no knowledge of chemistry, microbiology or manufacturing hygiene.

    HBO wouldn't air it if it wasn't a hit piece.
  • PhilGeis said:


    HBO wouldn't air it if it wasn't a hit piece.
    I suspected as much...but I try to give everyone the benefit of the doubt...at least once. :) 
  • @Graillotion It is available to stream on HBOMax, with subscription, using the website or a phone app.
    I haven't watched it because I'm pretty sure it will make me angry in much the same way trying to prove to someone that EWG is a lobbying organization by showing them EWG's publicly available tax documents when they feel like EWG is really experts in cosmetics because they have such a helpful website that tells them what is good and bad.
  • PerryPerry Administrator, Professional Chemist
    @Graillotion @PhilGeis - two years ago the producers of the documentary contacted me about it. I believe we had one phone call & we never connected again. Guess they didn’t find what I had to say helpful for the do documentary they wanted to make. Yes, the snippets I heard is just propagating the same old debunked BS. Even the old “EU bans 1500 ingredients but FDA only bans 11” nonsense argument. 
  • PhilGeisPhilGeis Member, Professional formulator
    Right, EU's ingredient ban comparison is a ridiculous - ingredients no one would use. 
       
  • I believe that the US cosmetic industry needs more regulation. I'm always shocked reading how some people don't do any tests or carry out stability tests while keeping the product in the car, and at the same time I get mad when I read that small companies don't test their products, where small companies in Europe do tests, and the lack of tests is a typical problem for small businesses in the US. But articles about how small businesses are not safe come out globally and also affect customers in Europe who are becoming wary of smaller businesses.
    The main problem is that anyone in the US can sell their cosmetics. If I want to sell cosmetics in Europe, I have to register the product with the safety report. As far as I know, registration in the US is not obligatory. To register a product in Europe, I need a safety report made by an authorized person. I cannot make such a report myself if I don't have the appropriate education and qualifications. Such a person has no interest in confirming the safety of not tested product. Stability test and challenge test are mandatory.
    https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02009R1223-20190813&from=EN
    Clear rules that must be followed are crucial - if you know that you need to perform stability tests, challenge tests, confirm substance limits, no animal testing, everything is simpler and there is no room for interpretation.
    I don't think retailers are the reason for the lack of tests and preservatives. Even retailers that have the clean categories allow the use of phenoxyethanol and many other preservatives, mainly parabens and formaldehyde donors are not allowed. 
    The customers are definitely not guilty. When they see that many companies don't use preservatives, and such products are sold in large retailers, they begin to believe that preservatives are not needed. I remember a sentence from one customer review of such a product, "They don't use unnecessary preservatives".
    In Europe, I have never heard of a case of someone selling untested home-made products. There are no platforms designed for this purpose. Probably someone tried to do it, but surely the number of such cases is much smaller.
    List of the banned substances don't make a big difference, because they are not used anyway, but some substances have additional requirements, e.g. "Petrolatum, except if the full refining history is known
    and it can be shown that the substance from which it is
    produced is not a carcinogen." I'm not sure if there is such an official requirement in the US. It's definitely part of the "clean categories" of retailers. 
    In general, I think clean categories come from these vague regulations. If a retailer has clean categories in the US, the same one in Europe has categories with products of natural origin or with eco-friendly packaging. No "free of".
    In the US, I also see some inaccuracies, as in the case of the use of salicylic acid in cosmetics. Apparently it cannot be used, but it is used.
  • LabLab Member
    [ LONG TEXT ALERT :D ]

    Hi perry, happy to hear we have a webinar coming soon! This is a very interesting topic for a number of reasons, even more so in post-Brexit times where initially there was a lot of confusion in the sector (Ireland united again? Who knows!).

    My opinion may be a little out of date as I don't live in the US, so it's based solely on comparisons I can make with my country's legislation, which can lead to bias on my part as things are a little stricter here. I apologize if I'm incorrect at any point.

    Well, I believe more regulation is needed. For me, it's a little strange to see so many people talking about "making cosmetics" so naturally. You see, I'm not condemning the "craft movement", but it hurts my ears a little to see so many people who don't have a basic knowledge of good manufacturing practices mixing things up at random and saying "eureka". I think it is important to nurture a love for cosmetics in this case, but common sense should not be exceeded. Lemon is a good fruit, many like it, it can have several health benefits, but we don't even pass it on the skin. But there are still people who don't know this, and when we apply this concept to a whole world of unknown ingredients, things get more complicated.

    Around here, it's difficult for anyone who doesn't own a company to buy raw materials, suppliers don't sell because they don't want to risk it if something goes wrong (and obviously to avoid problems with the law). There are supplier companies that sell to industries in large quantities and supplier companies that sell to small businesses, such as laboratories and pharmacies, but even these are not at risk. Anyway. That wouldn't stop anyone from not trying to become an alchemist. You can find many ingredients available on online platforms that sell all sorts of things (Amazon, Mercado Livre, and so on...), but many come without documentation, which is really, really bad if they catch you.

    Anyway, in my eyes, yes, anyone should be able to make cosmetics. There is no exact training for this, nothing would prevent it... but this must happen within a specific scenario, with rules, regulations, training and safety. I'm not talking about banning "controversial" ingredients, I'm talking about personal safety and the safety of the people who will buy the product. I imagine that it is often not well known the environment where the cosmetic was formulated, by whom, with what equipment and the source of the raw materials. But...

    ... But I also don't think we can blame people for being distrustful of big brands and wanting the best for their own health and that of others. The fault, in general, is the lack of information that affects them. And we know "who" is behind it. Wanting good for themselves, people end up doing themselves harm or subjecting themselves to high risks. In addition to a whole regulation/registration (which I imagine makes these people turn up their noses and not immediately understand some more complex things) there could be an incentive on the part of some government agency or program that encourages (and supervises) the production of products safely while maintaining the autonomy of people within this context so that they don't feel so limited despite the rules. It's a gradual way of changing things and it generates a long-term adaptation - at least no one is even more unhappy. It sounds more like a fairy tale I know.

    Wow, sorry for the long text! It's hard to express an opinion from an outsider, but I hope it made sense.

    Thank you! 
  • PhilGeisPhilGeis Member, Professional formulator
    @grapefruit22

    Wrong.  Retailers' priority lists ARE responsible.  In US and EU.  Sephora, Target Walmart, etc - all encourage use of garbage preservative systems.  I've consulted with contamination incidents clearly provoked by these lists.

    There are EU folks who make and sell cosmetics AND participate on THIS Chemists Corner who observe they do not test and express ignorance of manufacturing hygiene.  As I noted before - the "test" means little - esp. when folks know nothing off manufacturing hygiene.  You might also take a look at RAPEX list of cosmetic recalls.

    "Clean categories" what does that mean and why should a marketing term find technical credibility n regulation?  That phenoxy is "allowed" does not mean it's used or folks chasing that marketing claim develp effective systems or make them appropriately.
     
  • @PhilGeis I wrote about a case where the company doesn't use any preservatives at all. If retailers have a "clean" policy (it doesn't mean they only sell such products), then these products cannot contain certain ingredients from the list (only if company wants this label). Triclosan, formaldehyde donors and parabens are usually listed in these prohibited ingredients, which means they can use other preservatives - Phenoxyethanol, Chlorphenesin, Disodium Edta and the rest. If a company doesn't use preservatives, even though retailers allow them to be used even if you want to be "clean", then that is a choice of that company, not the retailer.
    As for GMP, while preparing the safety report, you must specify the production location and confirm the use of GMP. Premises are registered and controlled. Just because these rules exist, it doesn't mean that everyone follows them, but if someone doesn't need to register their business, produces cosmetics in the bathroom, doesn't test their mass for microbiological purity after production, and doesn't have to expect any inspection, the probability that they will sell a contaminated product is bigger.
  • MarkBroussardMarkBroussard Member, Professional Chemist
    The industry has a lot of self-regulating features in that manufacturers of products can be sued by individual consumers and/or class action and regulatory enforcement via complaints reporting to the FDA. 

    In addition, I suspect that there are not quite as many uneducated, uninformed product marketers who are self manufacturing as one might think and those are most likely found on ETSY and similar websites.  But, this is an area where some additional regulation could be considered.  

    Rather, most small companies use contract manufacturers who have an incentive to make sure the products meet safety requirements as they are unlikely to put their own business in jeopardy for the sake of a client's desire to manufacture an unsafe product.

    The one issue I do have regarding regulation is the 1% labelling rule since it provides for lack of fully transparency in labeling products.  I don't see any good reason why all ingredients are not required to be listed in descending order of inclusion in the product.
    Chemist/Microbiologist formulating in the Organic & Naturals & Clean Beauty arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program/Clean At Sephora/Credo Clean guidelines focused skincare & haircare products. 

    See website for details www.desertinbloomcosmeticslab.com
  • MarkBroussardMarkBroussard Member, Professional Chemist
    @grapefruit22

    There seems to be a misperception that "Clean" policies of retailers implies that preservatives do not need to be used.  That is not correct.  The Clean policy will prohibit the use of certain preservatives and ingredients if you want to sell through that retailer, but all reputable retailers require documentation validating that you are manufacturing a safe product.

    It is actually not that easy for a brand to get a major retailer to stock the brand's products.  The retailers have more companies approaching them than they can possibly deal with, so they select to represent brands and products that they think their client base will purchase.  The retailers are another check on the system.
    Chemist/Microbiologist formulating in the Organic & Naturals & Clean Beauty arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program/Clean At Sephora/Credo Clean guidelines focused skincare & haircare products. 

    See website for details www.desertinbloomcosmeticslab.com
  • Bill_TogeBill_Toge Member, Professional Chemist

    PhilGeis said:
    Right, EU's ingredient ban comparison is a ridiculous - ingredients no one would use. 
       
    true, and the legislative process is completely different - ever since the European regulations were brought in in 1976, there's been advisory panel whose entire job is to evaluate the safety of materials in question, and submit recommended courses of action to the European Parliament (as a bonus, this also makes the process very resistant to lobbying)
    and in reality, the amount of materials banned due to their advice amounts to maybe a few dozen, certainly no more than 100
    across the pond, this is another job delegated to the already overstretched FDA, and for this reason the wheels turn much more slowly
    UK based cosmetic chemist with 13 years' experience at the bench. I've worked with pretty much everything apart from pressed powders, soap, solid lipstick and aerosols.
  • Agree. Our manufacturing is based in Malaysia which has strong GMP Certification. Enforcement by regulatory authorities is always a struggle for any country.

    We mainly focus on Private Label / OEM for local and overseas brands, including the USA and Europe. And you guessed it, we have found barriers to entry to the USA almost non-existent. And the EU is very strict in our experience. And the same for the Japanese brands we manufacture.
    Dr. Mike Thair
    Cofounder & Chief Formulator
    Indochine Natural
  • PhilGeisPhilGeis Member, Professional formulator
    edited April 30
    @grapefruit22
    I understand EU reg's quite well and know not all in EU follow them by engaging with inspectors who know little about cosmetic quality any more than US folks using garbage "clean" systems and blowing off GMP's.   
    EU also has the technical fantasy of PAO that clearly gives license to garbage systems.  I've encountered folks using PAO down  to 6 month - one at 3.   We know consumers do not respect ex dates. 
    Let's not discuss "clean" further - we all know it's a marketing claim that sadly offers garbage preservation and unfortunately has traction in US and EU.

    Bottom line (rather than opinion )- what are the data?
    One might look at recalls - comparing RAPEX to FDA enforcement.  Historically, there has been little to no difference
  • PhilGeisPhilGeis Member, Professional formulator
    But to the question - legislation proposed largely demands big companies do what they're doing now. and it's largely paperwork.  It lets small guys largely off the hook.  The rub - the extents that small guys will comply and FDA has resources to enforce for small operations.  

    For EU folks that comply with the directive, they run their stuff by a qualified person.  There aren't many folks of any degree with enough expertise in judging preservative or manufacturing systems and you'd be very hard pressed to find one among those in field of  "pharmacy, toxicology, dermatology, medicine or a similar discipline" even adding chemist , biochemist and veterinarian.

    US regulation would pick up some guys at the margin - getting them to pass USP and write down their GMP's - at best, marginally limiting contamination from operations and projected in use.
  • PerryPerry Administrator, Professional Chemist
    Thanks everyone for your thoughtful comments. 

    I generally think new regulations should only be created to solve a problem. And there should be a measurable way to show whether the new rule solves the problem or not.

    For example, before the 1970s products were sold without any requirement to list ingredients. This was fine for most people, but there was a significant portion of the population that had allergies to one or another ingredient. Therefore requiring companies to list ingredients made sense. Presumably it warned consumers sensitive to specific ingredients & reduced negative reactions overall. It makes sense for both consumer & manufacturers.

    Similarly, banning ingredients like mercury, known to harm a large segment of the population also makes sense.

    But it seems to me there aren’t any measurable problems that more regulation of the cosmetic industry would solve.

    For example Cosmetics haven’t been shown to cause an increase in cancer. So rules removing potential carcinogens don’t make sense.

    I understand that allowing kitchen crafters to sell products made under non-GMP conditions is not ideal, but restricting this practice would be incredibly difficult & the problem it’s attempting to solve is not very large. How many people are significantly harmed by the microbial contaminated product they bought off Etsy or at a farmers market? I suspect not many. If this was a big, measurable problem then more restrictions make sense. But on some level consumers need to be smarter about who they buy from.

    Overall, I’m not against new regulations. I just haven’t seen any new proposed rules that solve any problem caused by cosmetics. 
  • PerryPerry Administrator, Professional Chemist
    It’s also notable to me that if you compare the majority of products sold in the US vs EU, they really aren’t substantially different. So, what good is the extra layers of EU regulation really doing?
  • @PhilGeis It is still not comparable to handcrafts (made at home, without PAO or anything) like: 5% salicylic acid peeling, pseudo-medical creams against eczema, neuropathy creams, intimate area lightening creams, and much more. These products have hundreds or thousands of sales. Sellers have statements under products that they are not responsible for anything. 
    The statistics cannot be compared in this case, because the scale of unregistered products described above in the US is much bigger.
  • The average business in the US, even a small one but run by a professional, likely follows GMP even when not imposed on them, so this new regulation to me is not good.
    But handcrafts scare me. Besides the usual things like creams or oils, they sell really strange products like Vagina Tightener. Or super strong peels - people can get scarring from it, the problem is not only potential contamination. As for contamination, I don't know if it is even possible to measure how many people have been harmed. Contamination can develop over time and the person using the product may not associate the symptoms with the product he/she has been using for a month. But even if it's a small number, it's still not worth changing?
  • PerryPerry Administrator, Professional Chemist
    edited May 6
    @grapefruit22 - Certainly, regulations that reduced the chances of someone getting injured by a homemade product could help. But the philosophy that rules in the US is that we want the minimum amount of rules so as not to inhibit innovation.

    Plus, more rules means more enforcement which means a growth of a government agency. That costs money. Again, that's not encouraged in the US.

    And if there is not a huge, measurable problem, spending lots of money to prevent it may not really make sense.

  • PattsiPattsi Member
    Interesting topic.

    mikethair said:
    we have found barriers to entry to the USA almost non-existent. And the EU is very strict in our experience. And the same for the Japanese brands we manufacture.
    Totally agree on this, this maybe one of many reasons why so many weird stuff from China can be found and bought online and offline, well to be fair, weird stuff can be found anywhere around the globe.

    PhilGeis said:

    Wrong.  Retailers' priority lists ARE responsible.  In US and EU.  Sephora, Target Walmart, etc - all encourage use of garbage preservative systems.  
    I have to agree on this.  

    As for handcrafts or homemade.
    Honestly I don't see a solution for this issue if it were to be pushed to state-level government, I am quite positive it be would become politicized and somehow make things more complicated.  
  • PhilGeisPhilGeis Member, Professional formulator
    There certainly are barriers for import of cosmetics. e.g. https://www.accessdata.fda.gov/cms_ia/industry_53.html

    Some ports of entry are known to be more demanding than others.

    I've successfully argued with FDA such cases for clients.
  • PhilGeisPhilGeis Member, Professional formulator
    edited May 6
    The primary risk for cosmetics is microbiological, not chemical.    Hobbyists, flea marketers and the like will always do as they wish and FDA will never have resources to address their issues even if they knew what to do.    
    Significant/magnitude risk (as recall) is realized in small to midsized operations as a function of poor, politically-correct  preservation and half-assed manufacturing hygiene.  There is no mechanism to assess in use contamination but that is even greater with poor preservation.

     
     Virtually every recalled product has passing preservative testing data  and "GMP's" 
     Legislators know nothing of the industry (witness classic PAO idiocy). EU (and proposed US legislation) merely establishes a paperwork confirmation, addiung no effective value. Big cosmetic writes most of the text at the fed level and little guys are usually exempted or greatly limited/delayed for enforcement.  Some states (e.g. California) are more influenced by the chemophobes and their crazy stuff is typically very focused (bans of micro plastics, PFAS, formaldehyde releasers, parabens, whatever).
    FDA regulations and enforcement based on legislation is the reality - not legislation per se.  The Agency is focused on drugs and vaccines (CDER),  Cosmetics are regulated as secondary priority by the foods guys (CFSAN).

    I represented P&G for over a decade at state and fed level for cosmetics and other issues.   In the big legislation/regulation picture, cosmetics are a secondary if not tertiary concern.   Folks might look at the original FD&C act history to understand dynamics involved in such regulation - https://scholarship.law.duke.edu/cgi/viewcontent.cgi?article=1937&context=lcp

     
  • @Perry Yes, recently I also had thoughts that there are a lot of such products and sellers in the US, because they have many customers and people are willing to buy these handcrafts, even if they can buy such a product in a store at a similar price. After all, in the EU you can also easily buy cosmetics ingredients and make them yourself, so it doesn't make much difference whether you buy the ingredients and make the product yourself at home, or buy a product made at home by someone else.
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